Bioavailability of Blackberry Juice Anthocyanins

Healthy Clinical Trial

Official title:

Influence of Ethanol in the Bioavailability of Blackberry Juice Anthocyanins in Normal Weight and Overweight/Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613715
• Other study ID #: VINOFLAVO_01
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2015
• Last updated: November 20, 2015
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial Summary

The main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.

Description:

Anthocyanins (ANT), a particular class of flavonoids that can be found in red wine and red fruits, have been associated with relevant health benefits. It has become clear that the flavonoid bioactive forms in vivo are not necessarily those which occur in nature, but metabolites arising from them after absorption. Therefore, it is important to identify which ANT metabolites are responsible for their health benefits. Since ANT can prevent/treat some of the metabolic features of obesity it is also crucial to study whether ANT bioavailability is not compromised in obesity.

An anthropometric evaluation will allow the classification of subjects according to their body mass index (BMI). A complete medical examination including the assessment of clinical laboratory parameters will also be performed to characterize the health status of recruited subjects.

Before the beginning of the study, the last fecal sample obtained will be collected. Urine samples and peripheral venous blood (10 ml) will be collected from 10 h-fasting subjects. Afterwards, each volunteer will consume 250 ml of blackberry juice with or without ethanol (visit 1 and 2) and blood samples will be collected 15, 30, 60 and 120 min after juice ingestion. Another urine sample will be collected at 120 min. The first fecal sample obtained at least 6 h after juice ingestion will be collected. Blood pressure (0 and 120 min) and glycaemic response (0, 15, 30, 60 and 120 min) will be measured in each visit.

Ethanol was added to the blackberry juice to mimic the concentration presented in red wine (12%).

A thorough screening analysis for ANT will be performed in plasma and urine samples collected from the volunteers at different time points. Fecal samples will also be collected to evaluate the relationship between the presence of ANT metabolites and the gut microbiota composition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Men and women

• Age 18-40 years

• BMI>18 kg/m2

• Willing and able to provide written consent

Exclusion Criteria:

• Subjects with current or previous CVD, diabetes or other severe chronic disease

• Subjects under prescription of any chronic medication

• Pregnant or breast-feeding subjects

• Intake of antibiotics in the last 3 months prior to the beginning of the intervention

• Intake of red fruits or red wine in the last 24 h prior to the beginning of the intervention

• Subjects involved in any clinical or food study within the preceding month

• Subjects with a diagnosis of any digestive disease including functional bowel disorder such as IBS

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Blackberry juice with 12% ethanol

• Blackberry juice

Locations

Country	Name	City	State
Portugal	CINTESIS - Faculty of Medicine of the University of Porto	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Center for Health Technology and Services Research, Vinoflavo

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of anthocyanins and anthocyanins metabolites		At baseline and 15, 30, 60 and 120 minutes after juices consumption	No
Secondary	Urinary concentrations of anthocyanins and anthocyanins metabolites		At baseline and 120 minutes after juices consumption	No
Secondary	Fecal concentrations of anthocyanins and anthocyanins metabolites		At baseline and at least 6 h after juices consumption	No
Secondary	Number of copies of bacterias presented in fecal samples		At baseline and at least 6 h after juices consumption	No
Secondary	Blood pressure measured in the left upper arm using an automatic blood pressure monitor		At baseline and 120 minutes after juices consumption	No
Secondary	Capillary blood glucose concentration		At baseline and 15, 30, 60 and 120 minutes after juices consumption	No